Cleared Traditional

K152628 - Pulse H20h!

K152628 is an FDA 510(k) clearance for Pulse H20h!, manufactured by Toaster Labs, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code NUC cleared through the Traditional 510(k) pathway after a 300-day FDA review.

K152628 · Toaster Labs, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2016
Decision
300d
Days
Class 2
Risk

K152628 is an FDA 510(k) clearance for the Pulse H20h!. Classified as Lubricant, Personal (product code NUC), Class II - Special Controls.

Submitted by Toaster Labs, Inc. (Seattle, US). The FDA issued a Cleared decision on July 11, 2016 after a review of 300 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5300 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Toaster Labs, Inc. devices

FDA 510(k) Submission Details - K152628

510(k) Number K152628 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2015
Decision Date July 11, 2016
Days to Decision 300 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
140d slower than avg
Panel avg: 160d · This submission: 300d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NUC Device Classification - Class 2, Special Controls

Product Code NUC Lubricant, Personal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5300
Definition This Device Is A Personal Lubricant, For Penile And/or Vaginal Application, Intended To Moisturize And Lubricate, To Enhance The Ease And Comfort Of Intimate Sexual Activity, And Supplement The Body's Natural Lubrication. This Product May Or May Not Be Compatible With Natural Rubber Latex, Polyisoprene, And/or Polyurethane Condoms.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - NUC Lubricant, Personal

All 131
Devices cleared under the same product code (NUC) and FDA review panel - the closest regulatory comparables to K152628.
Flip Lube
K171516 · Imquest Biosciences, Inc. · Feb 2018
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K173504 · Reckitt Benckiser, LLC · Jan 2018
Trojan Chain Reaction Personal Lubricant
K161544 · Church & Dwight Co., Inc. · Aug 2016
UltraSmooth Lubricating Liquid, and Medline Lubricating Liquid and Vaginal Moisturizer
K143529 · Medline Industries, Inc. · Aug 2015
Medline Natural Lubricating Liquid
K143322 · Medline Industries, Inc. · Jul 2015
Trojan Riviera Personal Lubricant
K150886 · Church & Dwight Co., Inc. · Jul 2015